Gemcitabine combined with cisplatin as first-line treatment in patients 60 years or older with epithelial ovarian cancer: a phase II study

Bauknecht, Thomas; Hefti, A; Morack, G; Villena-Heinsen, C; Wallwiener, D.; Elling, Dirk; Minckwitz, Gϋnter von; Mansouri, K.; Blatter, J.; Breitbach, G. P.

doi:10.1046/j.1525-1438.2003.13039.x

Cited by 15 publications

(6 citation statements)

References 18 publications

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“…These results are promising when compared with a median overall survival rate of 36–39 months for subjects treated with paclitaxel/platinum‐containing chemotherapy as reported in a systemic review of three large studies, which included stage II cancer in addition to stage III and stage IV cancer 5 . More interestingly, our results are very similar to the experience of Bauknecht et al , who, in a phase II study with gemcitabine and cisplatin as first‐line treatment of people older than 60 years with FIGO stage IIIC or stage IV epithelial ovarian carcinoma, found an overall response rate of 62.2% (95% CI, 44.8–77.5%) and a median survival of 27.7 months (95% CI, 14.3–40.8 months) 18 . Also, Nogue et al reported a similar study with gemcitabine and cisplatin, with an overall clinical response rate of 70.7% (95% CI 56.8–84.6%), a median overall survival of 23.4 months (95% CI 15.9–29.9 months) and a median progression‐free survival time of 10.4 months (95% CI 9.4–13.5 months) 19 .…”

Section: Discussionsupporting

confidence: 88%

“…5 More interestingly, our results are very similar to the experience of Bauknecht et al, who, in a phase II study with gemcitabine and cisplatin as first-line treatment of people older than 60 years with FIGO stage IIIC or stage IV epithelial ovarian carcinoma, found an overall response rate of 62.2% (95% CI, 44.8-77.5%) and a median survival of 27.7 months (95% CI, 14.3-40.8 months). 18 Also, Nogue et al reported a similar study with gemcitabine and cisplatin, with an overall clinical response rate of 70.7% (95% CI 56.8-84.6%), a median overall survival of 23.4 months (95% CI 15.9-29.9 months) and a median progression-free survival time of 10.4 months (95% CI 9.4-13.5 months). 19 In this respect, our study suggests that the combination of gemcitabine and carboplatin seems to be as efficacious as combined gemcitabine and cisplatin; in the same way, paclitaxel and carboplatin is equally efficacious as paclitaxel and cisplatin.…”

Section: Discussionmentioning

confidence: 83%

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First‐line gemcitabine and carboplatin in advanced ovarian carcinoma: a phase II study

Tay

Ilanchadran

Tan

2006

BJOG

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Objectives To evaluate tumour response rate and toxicities of gemcitabine and carboplatin in chemonaive subjects with advanced epithelial ovarian cancer.Design A phase II study.Setting Gynaecologic oncologic unit.Population Twenty chemonaive International Federation of Gynecology and Obstetrics (FIGO) stage IIIc and stage IV subjects with ovarian cancer.Main outcome measures Tumour response, disease free and overall survival and toxicity.Methods Intravenous gemcitabine 1000 mg/m 2 on day 1 and day 8 and carboplatin at area under centre (AUC) = 5 on day 1 were administered three weekly for six cycles. Subjects who received more than three cycles of chemotherapy were eligible for assessment of tumour response, while all the cycles of chemotherapy were assessed for toxicities.Results The mean age of the subjects was 57.3 years, and the median follow up was 38.7 months. Of the 18 eligible subjects analysed, 11 (61.1%) showed a complete clinical response, and the overall response rate was 83.3% (15/18). The median overall survival was 29.2 [95% (confidence interval) CI 22.8-35.6] months, and the median progression-free survival was 11.6 (95% CI 4.7-18.5) months. WHO grade 3 anaemia, neutropenia and thrombocytopenia was 7.6, 9.5 and 0%, respectively, on day 8, and 15.5, 12.2 and 15.5%, respectively, on day 15. Two subjects required a total of three hospital admissions for neutropenic sepsis, and two required five hospital admissions for platelet transfusion for severe thrombocytopenia.Conclusion Chemonaive advanced ovarian cancer showed a high response rate to combined gemcitabine and carboplatin chemotherapy. The subjects developed moderate adverse reactions. Phase III study to evaluate the role of combined gemcitabine and carboplatin as first-line chemotherapy in ovarian cancer is warranted.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 83%

First‐line gemcitabine and carboplatin in advanced ovarian carcinoma: a phase II study

Tay

Ilanchadran

Tan

2006

BJOG

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“…The synergy (10 -12) and clinical activity of systemic cisplatin and gemcitabine in patients with ovarian cancer are well described both in the chemotherapy-naive and relapse populations (13,14). Several characteristics of gemcitabine have suggested that it is a reasonable candidate for exploration in the i.p.…”

Section: Introductionmentioning

confidence: 99%

Intraperitoneal Cisplatin with Intraperitoneal Gemcitabine in Patients with Epithelial Ovarian Cancer

Sabbatini¹,

Aghajanian²,

Leitao³

et al. 2004

Clinical Cancer Research

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Purpose: The aims of this study were to determine the dose and schedule of i.p. cisplatin with i.p. gemcitabine in patients with persistent disease at second-look assessment, the toxicity of this regimen, and the time to treatment failure and overall survival.Experimental Design: We performed a Phase I/II evaluation of i.p. cisplatin at 75 mg/m 2 on day 1 with planned gemcitabine at 500, 750, 1000, or 1250 mg/m 2 i.p. on days 1, 8, and 15 on a 28-day schedule for four courses. Eligible patients completed surgical cytoreduction followed by adjuvant platinum-based chemotherapy. They had second-look assessment showing microscopic or macroscopic (<1 cm) disease, followed by i.p. port placement.Results: The Phase I dose-limiting toxicity was grade 3 thrombocytopenia at day 15 on dose level 1 (n ‫؍‬ 5). The protocol was amended, and the Phase II portion accrued to 30 patients, who were given i.p. cisplatin (75 mg/m 2 ) on day 1 and gemcitabine at 500 mg/m 2 on days 1 and 8 on a 21-day schedule for four courses. Nine patients were removed from the study: one each for hypersensitivity, cellulitis, and i.p. port malfunction; two for progression of disease; and four for renal toxicity. Other toxicities included grade 3 nausea (7%) and transient grade 3 neuropathy (3%). Grade 1 or 2 neuropathy was frequently seen (80%). Conclusions: The median time to treatment failure and overall survival of 15.9 months and 43.5 months, respectively, are consistent with our historical data in patients receiving i.p. platinum-based regimens for consolidation. The fibrotic changes seen in explored patients suggest local toxicity of this combination. The absolute benefit of i.p. consolidation requires randomized trials to assess efficacy.

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“…The addition of gemcitabine to cisplatin may have synergistic tumoricidal activity even in women with platinum-resistant tumors. It is postulated that gemcitabine prevents DNA synthesis and repair and thus helps circumvent platinum resistance [11,12] Several studies have evaluated the combination gemcitabine and cisplatin (or carboplatin) among women with primary [13,14] and recurrent [2,[15][16][17][18][19][20][21][22] ovarian cancer.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of a modified regimen of gemcitabine and cisplatin among women with recurrent epithelial ovarian cancer

Eltabbakh

Donovan

Eltabbakh

2016

JST

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Objective: To assess the efficacy, side effects and progression-free interval of a modified regimen of the combination of gemcitabine and cisplatin among women with recurrent epithelial ovarian cancer. Methods: Twenty-eight women with recurrent epithelial ovarian, primary peritoneal or fallopian tube cancers were treated with gemcitabine (500 mg/m 2) followed by cisplatin (50 mg/m 2) on days one and eight every three weeks. Patients' demographics, response, side effects, and progression-free interval were recorded. Result: The median age of patients was 61 (range 44-74 years). Twenty-three (82.1%) patients had platinum-sensitive and five (17.9%) had platinum-resistant tumors. The median number of prior chemotherapy regimens was two (range 1-4) and nine patients had > three prior regimens. The median number of cycles was six (range 2-10). Seventeen (60.7%) patients responded to chemotherapy (11 complete and six partial), six had stable disease and five had progression. The response rate was 69.6% and 20% among women with platinum-sensitive and platinum-resistant tumors, respectively (P = .024). The median (range) progression-free interval was six (2-12) and nine (4-12) months among all patients and patients who responded to chemotherapy, respectively. Four patients had dose reductions, four had delays and three had their chemotherapy terminated secondary to toxicity or patient desire. There were no chemotherapy-related mortality or hospital admissions. The incidence of grade 3-4 neutropenia, anemia, thrombocytopenia, and nausea or vomiting was 32.1%, 10.7%, 35.7%, and 10.7%, respectively. Conclusion: The combination gemcitabine and cisplatin is highly effective among women with recurrent ovarian cancer including those who are heavily pre-treated and is reasonably tolerated. Although, the combination is effective among women with plantinum-resistant tumors, these women have a lower response than women with platinum-sensitive tumors.

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Gemcitabine combined with cisplatin as first-line treatment in patients 60 years or older with epithelial ovarian cancer: a phase II study

Cited by 15 publications

References 18 publications

First‐line gemcitabine and carboplatin in advanced ovarian carcinoma: a phase II study

First‐line gemcitabine and carboplatin in advanced ovarian carcinoma: a phase II study

Intraperitoneal Cisplatin with Intraperitoneal Gemcitabine in Patients with Epithelial Ovarian Cancer

Efficacy of a modified regimen of gemcitabine and cisplatin among women with recurrent epithelial ovarian cancer

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